CESAREAN PACK- — Class I medical device recall Z-2359-2014
Terminated recall by Customed, Inc, reported 2014-09-10, distributed nationwide. Customed has determined that there is the possibility that packaging integrity may be compromised on different
| Recall number | Z-2359-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Customed, Inc, Fajardo, PR, United States |
| Recall initiated | 2014-05-20 |
| Classified | 2014-08-29 |
| Reported by FDA | 2014-09-10 |
| Terminated | 2017-08-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CR, DO, MX, TT |
| Reason classes | sterility, packaging |
| Lot numbers | 110061474, 112114590, 113026118, 113036391, 113057414, 113057820, 113078478, 113078607, 113099298, 113099579, 131110080, 131110413, 131110590, 131210974, 140111455, 140211743 |
Product
CESAREAN PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) BABY BLANKET PRINTED (1) BOWL PLASTIC WITH LID 80oz. (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR (1) CORD UMBILICAL CLAMP (1) MUCUSTRAP 20cc, 10FR. (1) BOWL UTILITY 32oz (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" (1) TUBE SUCTION CONNECT. ~"X 12' (1) TIP CAUTERY POLISHER (1) PENCIL CAUTERY ROCKER SWITCH (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) MAYO STAND COVER REINFORCED (10) LAP SPONGES PREWASH 18" X 18" XRD (1) BAG GLASSINE (2) SURGICAL BLADE #10 STAINLESS STEEL (1) EAR ULCER SYRINGE 2oz. (2) LIGHT GLOVE (1) BOWL UTILITY 16oz (4) DRAPE UTILITY WITH TAPE (2) DRAPE SHEET 41 " X 58" SMS (1) ELECTRODE DUAL DEPRES./GROUNDPAD EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Reason for recall
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2359-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.